Quick answers
- What is Protamine sulfate used for?
- The FDA-approved label (Protamine Sulfate, Fresenius Kabi USA, LLC, April 29, 2025) says: “Protamine Sulfate Injection, USP is indicated in the treatment of heparin overdosage.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Protamine sulfate have a boxed warning?
- Yes. The FDA label for Protamine Sulfate has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Protamine sulfate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Protamine sulfate been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Protamine sulfate?
- 2 companies list prescription products of Protamine sulfate in the FDA NDC Directory, including Fresenius Kabi USA, LLC and HF Acquisition Co LLC, DBA HealthFirst.
What Protamine sulfate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Protamine Sulfate Injection, USP is indicated in the treatment of heparin overdosage.
— FDA label: Protamine Sulfate, Fresenius Kabi USA, LLC, effective April 29, 2025. Read the full label on DailyMed →
The FDA has 5 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
5 of 5 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution |
|---|---|
| Route | Intravenous |
| Prescription products | 3 in the FDA NDC Directory |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Fresenius Kabi USA, LLC4 products
- HF Acquisition Co LLC, DBA HealthFirst1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (1)
- ANDA089454Fresenius Kabi USA · April 7, 1987
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 1796672, 1796676 |
|---|---|
| SPL set ID of the quoted label | c76876da-b9a8-45d0-9278-7df3288d3a06 |
| FDA labels (SPL) | 5 |
| FDA applications | 1 ANDA |
| Active ingredients (FDA) | PROTAMINE SULFATE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Protamine Sulfate, Fresenius Kabi USA, LLC, effective April 29, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →